Nucala Subcutaneous Injection Special Drug Use Investigation (Long-Term) (204524)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational Post Marketing Surveillance under actual drug use condition

Study drug and medical condition

• Name of medicine:
  NUCALA
• Study drug International non-proprietary name (INN) or common name:
  MEPOLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (R03DX09) mepolizumab

  mepolizumab
• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  This investigation is conducted to collect and evaluate information on safety and effectiveness of long term use of Nucala subcutaneous injection in Asthma patients in daily clinical practice.
• Outcomes:
  Information on safety and effectiveness of Nucala subcutaneous injection in daily clinical practice.
• Data analysis plan:
  Safety: The incidence of ADRs and 95% confidence interval will be calculated.; Effectiveness: The response rate based on the global assessment of effectiveness and its 95% confidence interval will be calculated. For comparison of the scores, etc. the summary statistics for values at the time of measurement and changes from baseline will be calculated.; Consideration of covariates: The covariate that affects safety (incidence of ADRs) and effectiveness (response rate) will be considered by calculating the odds ratio and its 95% confidence interval.